Bladder CancerNCT03193528
A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
An observational study of Bladder Cancer, run by Cedars-Sinai Medical Center at 6 sites in 2 countries.
Trial summary
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- How many people
- 450 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 30 Dec 2016to 13 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
Who may be able to join
- Age 18 years or older
- Have documented or reported gross hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Who cannot join
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat
- Have ureteral stents, nephrostomy tubes or bowel interposition
- Have recent genitourinary instrumentation (within 10 days prior to signing consent)
- Be unable or unwilling to complete the hematuria evaluation (i.e., cystoscopy and upper tract imaging)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States4 sites
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California Los Angeles
Los Angeles, California, 90095
University of Rochester Medical Center
Rochester, New York, 14627
Japan2 sites
Nara Precfecture Seiwa Medical Center
Nara, Nara
Department of Urology, Nara Medical University
Nara
About this study
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
Read the detailed description
Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.
Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.
Measured: 1 year
Secondary outcomes (2)
To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.
Measured: 1 year
To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start30 Dec 2016
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Texas, Nara Medical University, University of California, Los Angeles, Nonagen Bioscience Corporation, National Cancer Institute (NCI), University of Rochester, Nara Prefecture Seiwa Medical Center
- Responsible party
- Sponsor
- Investigators
- Charles Rosser, MD, Study director, Nonagen Bioscience CorporationHideki Furuya, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193528
- Sponsor's protocol ID
- Rosser-2015-7
- Other IDs
- R01CA198887
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lotan Y, Gupta A, Miyake M, Anai S, Luu M, Ahdoot M, Messing E, Peers G, Chin AI, Liu M, Tikhonekov S, Sakatani T, Shimizu T, Pagano I, Zheng Y, Zhang Z, Kim H, Josephson D, Furuya H, Rosser CJ. Prospective multicenter validation of a Urine-Based multiplex assay for risk stratification of patients presenting with gross hematuria. J Natl Cancer Inst. 2026 Aug 17:djag282. doi: 10.1093/jnci/djag282. Online ahead of print.
PubMed 42608795Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
PubMed 38167321Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.
PubMed 38045238
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Multiplex ELISA Assay for Evaluating Patients With Gross Hematuria for Bladder Cancer
- ClinicalTrials.gov ID
- NCT03193528
- Acronym / sponsor ID
- Rosser-2015-7
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, University of Texas, Nara Medical University, University of California, Los Angeles, Nonagen Bioscience Corporation, National Cancer Institute (NCI), University of Rochester, Nara Prefecture Seiwa Medical Center
- Study start
- 30 Dec 2016 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
Detailed description
Hematuria is the most common presentation of BCa with 22% of patients with gross hematuria harboring BCa. VUC is the most widely used urine-based assay for detecting BCa; however, it fails to detect approximately 50% of low-grade or early stage BCa when it is most curable.
Because of this severe limitation, patients with hematuria (microscopic or gross) will undergo an invasive examination of the urinary bladder, where a miniature camera is inserted into the bladder. We propose to improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, age 18 and older who have documented gross hematuria within the past 3 months who are referred for cystoscopy and are willing to participate
Key inclusion criteria (3 listed)
- Age 18 years or older
- Have documented or reported gross hematuria within 3 month of study enrollment
- Willing and able to give written informed consent
Key exclusion criteria (7 listed)
- Have history of BCa
- History of previous cancer (excluding basal and squamous cell skin cancer) within the past 3 years
- Have a known active urinary tract infection or urinary retention
- Have active stone disease (renal or bladder) or renal insufficiency (creatinine >2.0 mg/dL) Serum creatinine value can be up to 60 days before consent, otherwise repeat
- Have ureteral stents, nephrostomy tubes or bowel interposition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria.
Time frame: 1 year
2 secondary outcomes
To compare the sensitivity and specificity of the multiplex ELISA assay to VUC and NMP22® BladderChek to reference standard of cystoscopy in this cohort.
Time frame: 1 year
To develop a BCa risk calculator from this cohort using cutting edge machine learning techniques (e.g., random forest) incorporating biomarker data and clinical data.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 42608795Lotan Y, Gupta A, Miyake M, Anai S, Luu M, Ahdoot M, Messing E, Peers G, Chin AI, Liu M, Tikhonekov S, Sakatani T, Shimizu T, Pagano I, Zheng Y, Zhang Z, Kim H, Josephson D, Furuya H, Rosser CJ. Prospective multicenter validation of a Urine-Based multiplex assay for risk stratification of patients presenting with gross hematuria. J Natl Cancer Inst. 2026 Aug 17:djag282. doi: 10.1093/jnci/djag282. Online ahead of print.
- Derived from this study: PubMed 38167321Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. J Transl Med. 2024 Jan 2;22(1):8. doi: 10.1186/s12967-023-04811-2.
- Derived from this study: PubMed 38045238Furuya H, Sakatani T, Tanaka S, Murakami K, Waldron RT, Hogrefe W, Rosser CJ. Bladder cancer risk stratification with the Oncuria 10-plex bead-based urinalysis assay using three different Luminex xMAP instrumentation platforms. Res Sq [Preprint]. 2023 Nov 25:rs.3.rs-3635581. doi: 10.21203/rs.3.rs-3635581/v1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Rosser, MD study director
Nonagen Bioscience Corporation
Hideki Furuya, MD principal investigator
Cedars-Sinai Medical Center
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Cedars-Sinai Medical Center at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine the sensitivity and specificity of the multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples to reference standard of cystoscopy in a cohort of 450 participants presenting with gross hematuria. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03193528, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.